The Generic Pharmaceutical Association (GPhA) has urged CA-Governor Jerry Brown to veto the biosimilars bill on his desk. The bill, backed by Amgen and Genetech, among others, would require pharmacists to notify physicians and patients that they have substituted a biosimilar when filling a prescription. If a physician indicated no substitution is allowed, then none would be alllowed under the bill.
The GPhA and 30 allied organizations have protested. They sa restrictions on biosimilars will hurt patients and payers. They note similar legislation has been turned down in 10 of 18 other states, and passed with severe restrictions in 3 others. Only ND has passed a bill that fully represents the Amgen/Genentech view according to GPhA.
GPhA and its allies say such bills will hurt biosimilars and their uptake. And will prevent the State of CA from realizing up to $27.6 B in potential savings in the next 10 years as 11 blockbuster biologicals come off patent. Given the dollars at stake, GPhA says goverments, state and federal, should be looking at ways to promote biosimilar uptake. See Patent Docs.
In my view, due to the econmomic reasons cited, I do think governments at local, state, federal and international level will be looking to get biosimilars onto the market and into patients' hands. As world economies struggle, and developing nations battle to raise their health standards, it will be a matter of economics that drives biosimilar uptake. I see the current model for biologics and being particularly Western driven and unsustainable in the developing world due to high costs of many biologics. Change is inevitable in my view. One would be better of trying to envision the new model and how to dominate share within that view.
Posted by Bruce Lehr Oct 3rd 2013.